DEVICE: ENDOCAPSULE RECORDER (04953170328244)

Device Identifier (DI) Information

ENDOCAPSULE RECORDER
RE-10
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170328244
GS1

1
711789789 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Video capsule endoscopy system workstation An assembly of mains electricity (AC-powered) devices designed to receive, digitize, display, and store endoscopy video capsule endoscopy system data [e.g., real-time video imaging of the gastrointestinal (GI) tract (oesophagus, small bowel and colon)] as well as to provide data query and extended database functions, and interactions with other hospital information systems. It typically consists of a number of connected devices such as a computer, at least one visual display unit (VDU), a keyboard, a printer and the hardware and dedicated software to manage the data.
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FDA Product Code

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Product Code Product Code Name
NEZ SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ff32b639-9cd1-4d3d-8194-fde846853efd
March 29, 2018
2
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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